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Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

• Technical school diploma or equivalent combination of education and experience.
• Minimum 5-7 years' experience with Mechanical / Electronic part inspection in a manufacturing or production Environment.
• Experience in quality with machined / mechanical parts using GD&T interpretation, able to do programs for automatic inspection with Optical Vision Systems and CMMs. plus. Able to use Profilometers and special Microscopes for visual characteristics with other measuring tools and instruments.
• Knowledgeable with AS9102 FAIR (First Article Inspection Report) documentation and Inspection.
• Familiar with AQL, sampling methods and traceability.
• Strong verbal/written communication skills required for multi-faceted interactions with all levels of personnel within the organization, as well as any and all outside agents, including but not limited to; vendors, suppliers, customers, etc.
• Strong computer literacy, with MS Office/PC expertise and demonstrated experience with applicable systems, programs, equipment, etc.
• Must be a US Citizen.

• Train other inspection personnel on CMM software and manual measurement techniques.
• Perform Mechanical measurements and visual quality assessments of received items, work-in-progress and finished goods.
• Performs 1 st Piece Inspection on machined parts and inspection for product Quality Analysis.
• Inspect with thread gages, GO/NO-GO plug gages, V-Blocks, Gage Blocks, height stands, dial indicators, various types of ID/OD micrometers, inspection of thread Pitch Diameter with special gages.
• Generate spreadsheets for data collection, evaluate history of product and recommend on Sample Size as per an AQL
• Reconcile final inspection documentation for shipments
• Interact with source inspector as needed and part-take in source inspection duties if necessary.
• Read, understand and interpret Mechanical/Electronic drawings.
• Approve incoming materials by confirming specifications, conducting visual and physical measurement of the product., rejecting if necessary and processing part thru to the next step.
• Approve in-process production by confirming specifications, conducting visual, physical measurement and physical measurement of the product., communicating required adjustments to production supervisor.
• Approve finished products by confirming specifications, conducting visual and physical measurement of the product.
• Document inspection results by completing reports and logs, summarizing re-work and waste, and inputting data into quality database
• Always verify equipment is operational and calibrated, follow operating instructions and coordinate repairs
• Work with Engineering, Operations, and other sources to resolve issues and meet goals

• Bring initiatives and activities to closure in a timely manner through effective interaction with individuals, both internal and external to the Marotta organization (as required).
• Maintain and continue to elevate relationships with Business Development, Engineering, Operations, Customer Service and all other facets of the company
• Abide by all safety, quality, housekeeping and company policies/procedures to ensure compliance to various regulatory and internal system requirements
• Contribute to a positive and cooperative work environment through effective communication at all levels internal and external to the organization
• Actively participate in team meetings, improvement initiatives/programs, etc. to provide constructive recommendations and initiate actions to support company initiatives/goals
• Consistently demonstrate commitment to company values
• Keep management informed of area activities and of any significant problems
• Assume responsibility for related duties as required or assigned
• Ensure that work area and work areas of direct reports are clean, secure, and well maintained
• Complete special projects and miscellaneous assignments as required

• While performing the duties of this job, the employee can be exposed to fumes or airborne particles, moving mechanical parts and vibration. The noise level in the work environment may be loud.
• This job interacts both in a professional office environment and a manufacturing/machine shop environment. This role uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines, as well as environments inclusive of the appropriate eye, hearing and foot protection (as required).
• This is a full-time position. Overtime and weekend work may be required as job duties demand.
• Travel is rare but may be required to coordinate proper CMM inspection techniques with Suppliers.

• While performing the duties of this job, the employee is regularly required to talk and hear.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Vision and color vision must pass job-required vision screening
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, or crouch
• 
  The employee may be required to lift and/or move items weighing up to 25 pounds.

Duties:

• Primary responsibility is to execute routine Microbiology/Environmental monitoring, Raw Materials testing of bulk drug substance and drug product in a multi-product facility.
• Executes Raw Material sampling, Microbiological compendial testing and sampling of clean rooms (as applicable).
• Proficiency in 1-3 analytical methodologies.
• Performs technical and quality review of data.
• Responsible for routine lab maintenance work and quality and compliance activities.
• Performs duties under supervision and according to standard operating and QC procedures.
• Ensures that all data is organized and archived per appropriate workflows and SOPs.
• Works with GMP and non-GMP databases to ensure all samples are received, logged, stored, distributed and tracked within defined timelines.
• Interacts with Sample Management, QC laboratories and Raw Materials groups to prioritize samples, cross checks SOPs and protocols to ensure all samples have been received and distributed, troubleshoots discrepancies, and relays information back to line management to ensure all samples are tested per appropriate testing schedule.
• Coordinates shipment of samples to contract labs and other testing site.
• Maintain sampling and testing paper records, equipment logs and other controlled documentation.
• Ensure accuracy and completeness of sampling and testing in LIMS system and/or test records.
• Maintain cleanliness and orderliness of the labs.
• Perform QC-related data entry.
• Provides assistance to other group members as needed.
• Responsible for transferring samples from cleanrooms to the labs.
• Familiar with clean room gowning.

Skills:

• 1-3 years of GMP lab and/or clean room experience.
• Gowning and Aseptic techniques.
• Pipetting skills.
• Must be willing to work all shifts including weekend support if needed but primary work hours are during five days a week.

Education:

• Bachelor’s Degree in a Scientific Discipline, preferably in Microbiology

Role Title - Quality Control Analyst III, Analytical

Department- QC

Reports to- QC Manager, Analytical

FLSA -Exempt

Salary Range: $80k- $90k

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

COMPANY DESCRIPTION

Polaris Pharmaceuticals, Inc., an affiliate of the Polaris Group ( ), is a therapeutic protein drug manufacturer located in Vacaville, California. Polaris has a cGMP facility producing biological study drugs to support all Polaris Group clinical trials at various stages in the USA, Europe, and the Asian-Pacific region.The lead project of the company is now in clinical trials for patients with different types of cancer including mesothelioma, sarcoma, and glioblastoma. Polaris is seeking candidates to help with the production of this protein drug as well as the production of products for our clients and partners.

ROLE SUMMARY

The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples compliant with cGMP guidelines. The Analyst works independently on assays that he/she has mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

ROLE RESPONSIBILITIES

• Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Reviews test data for accuracy, data integrity, system suitability, and conformance against defined criteria/specifications.
• Provides technical support with troubleshooting of test methods, as needed.
• Identify and contribute to OOS/OOE/OOT investigations related to testing performed.
• Initiate and author deviation and laboratory investigations.
• Maintains the laboratory in an inspection-ready state.
• Develops and maintains proficiency in a broad range of trained test methods.
• Train analysts on test methods and procedures.
• Responsible for authoring Change Control records and leading the revision of written procedures as assigned.
• Holds self and others responsible to abide by department and company policies and practices.
• Adheres to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements.
• Manage reagent and equipment inventory for assigned areas of responsibilities.
• Responsible for sampling and testing of incoming raw materials

SKILLS

• Strong working knowledge of cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Works independently as well as in a team environment.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Strong documentation skills a must. The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation. Experience with Protein analytics, SDS-PAGE, separations technology for HPLC, Chromatography Data Systems (CDS) software such as OpenLab, subvisible particles testing (USP ), and CCIT preferred. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

QUALIFICATIONS

B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). Minimum of 5 years of relevant laboratory experience is desired.

Job Title: QC Specialist II

Location: Portsmouth, NH 03801

Duration: 12 Months

Pay rate: $33/hr on w2

Job Description:

The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing and stability studies when needed.

Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Running test samples for (but not limited to) investigations, transfers and validations.
• Reviewing assays
• Training others
• Has experience with: Change Control, Deviations, CAPAs, Tasks, EICRs, Investigations.
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
• Projects – such as method transfers, new instruments, method qualifications
• Use of Microsoft Suites (Word, Excel, PowerPoint)
• Use of Laboratory computer systems
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with *** DI policies, guidelines and procedures.
• Perform other duties as assigned.
• Strong ability to speak publicly.
• Strong ability to interpret data both alone and with guidance.
• Perform assigned, complex and/or varied tasks.
• Prioritization and problem solving.
• Comprehend and follow instructions.
• Direct, control and plan tasks/projects.
• Brainstorming
• Strong ability to communicate in both written and verbal format .
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Self-motivated team player
• Completes assignments on-time and accurately
• Displays commitment to quality and performs job functions to the best of his/her ability
• Relate to others in a team setting.
• Maintain positive attitude in a team environment.
• Timeliness in completing assigned tasks.
• Works entire assigned shift, including arriving on time

Has experience with or currently uses the following software:

• SoftmaxPro, Empower, SoloVPE
• Has experience with software validations including but not limited to: writing GMP procedures and validation documents and executing test scripts.
• Acts as a SME for at least one software system
• Communicates with cross functional teams to interpret needs and priorities.
• Has GMP experience within the pharmaceutical industry
• Can perform technical, root-cause analysis for some software errors
• Applies Data Integrity principles in all aspects of work, in compliance with *** DI policies, guidelines and procedures.
• Remains up to date on all assigned training activities.
• Performs other duties as assigned.

Education:

• Associate’s degree Microbiology, Biochemistry or Related Science Fields

Job Title: Quality Assurance Inspector

Duration: 12+ Months (Possible extension)

Location: Roswell, GA 30076

Onsite Role

Responsibilities:

• Inspects incoming product (components, subassemblies, labeling, finished goods) in accordance with internal facility standard operating procedures/work instructions or Part/Product Specifications.
• Inspects client manufactured, packaged, and labeled product in accordance with internal facility standard operating procedures/work instructions or Product Specifications.
• Follow documented procedures or test procedures to evaluate identified characteristics for conformance to product specifications via visual inspections (aided or unaided eye), functional testing, or physical testing via visual measurement system or Instron tensile equipment.
• Maintains accurate, legible, and organized records of performed inspections in compliance with Good Documentation Practices and properly prepares / reviews inspection paperwork.
• Prepares nonconformance documentation (where appropriate).
• Following Component Specification/Inspection Requirements appropriately determine sample size via statistical sampling plan (ASQ Z1.4 or C=0 plans); properly samples product in accordance with procedures/ specifications.
• Properly identifies and segregates product as to its inspection status (Pending, Reject, Accept etc.).
• Promote and adhere to Good Manufacturing and Documentation Practices (cGMP cGDP), and other applicable standards.

Education/Experience:

• High school diploma with relevant work experience (Associate's degree or higher preferred)
• Must have 1 or more years’ experience in medical device manufacturing QA/QC: inspection and/or verification of incoming materials, production samples, packaging samples, and/or labeling samples.
• Ability to use common measurement equipment (e.g., pin gauges, calipers, micrometers, visual measurement systems, steel rulers, and Instron tensile testing equipment).
• Ability to read and interpret engineering drawings/specs and capable of distinguishing between colors (component distinction and printed labeling).
• Experience working in both English and Metric systems of units.
• Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.
• Proficient in the use of MS Office applications and electronic documentation systems.

QC Lab Technician 1

Duration: 9 months

Location: St Louis, MO- Onsite

Pay Rate: $24-$26.00/hr

Shift: Shift Could be either 1st/2nd /3rd shift -That may differ - Shift discussion during Interview- pls ensure candidate should be comfortable on either shift

Education: Bachelor's degree in Science, or a related field preferred

Experience: Minimum of 2 years of experience in quality control

Top 3 Skills: Strong attention to detail and visual inspection skills, proficiency in quality testing and use of tools, documentation and data analysis reporting skills.

Additional Physical Fit Testing Required

Purpose of the Job

The Quality Control Technician I provides quality control services to produce high quality Client-Client products in a cost effective manner while maintaining excellent safety, human relations, and environmental standards.

Job Context

The Quality Control Technician I will operate within Client-Client to provide quality testing expertise for raw and finished product materials. The person in this role will interact with all local staff. They will be knowledgeable of the Quality requirements for Client-Client. They will ensure that laboratory procedures and equipment are kept in superior working order. Handling and disposing of Hazard waste and chemicals are part of normal activities.

Job Content

1. Perform Lab Tests: Independently carry out routine quality control analyses following set procedures.
2. Data Integrity & Documentation: Confidently handle all steps of testing, including preparation, execution, and accurate documentation.
3. Check Results: Review test results for accuracy and consistency before submission.
4. Report Issues: Identify and report any quality deviations (e.g., OOS) according to protocols.
5. Initial OOS Testing: Conduct first-level tests for out-of-spec results as per procedures.
6. Escalate Issues: Identify recurring problems and escalate them to the appropriate person or team.
7. Maintain Equipment: Take care of assigned lab equipment, including calibration and basic maintenance, following GMP and safety standards.
8. Meet Deadlines: Complete tests and submit results within required timeframes.
9. Follow Safety Rules: Work in line with all safety, health, and environmental (SHE) guidelines.
10. Problem Solving: Analyze special samples to help resolve lab or support in production issues.
11. Manage Supplies: Order and manage lab materials and reagents to avoid shortages.
12. Flexibility: Perform other tasks as needed to support lab operations.
13. Physical requirements: Requires stand for extended periods while performing inspections or quality checks, repetitive hand and arm movements to handle samples and to operate testing equipment, ability to maintain focus and attention to detail during routine and repetitive tasks.

Knowledge and Educational Level

Education: Bachelor's degree in Science, or a related field preferred.

Experience: Minimum of 2 years of experience in quality control.

Fluency in local language a requirement, other languages encouraged.

Must have lab experience/ HPLC & GC exp

Job Title: QC Lab Technician

Duration: 09+ Months Contract

Location: St. Louis, MO 63147

Shift: Monday – Friday; 6:00AM – 2:00PM (bit flexible)

Pay Rate: $26/hr on w2 (all inclusive)

Job Summary:

The Quality Control Technician I will operate to provide quality testing expertise for raw and finished product materials. The person in this role will interact with all local staff. They will be knowledgeable of the Quality requirements. They will ensure that laboratory procedures and equipment are kept in superior working order. Handling and disposing of Hazard waste and chemicals are part of normal activities.

Job Content

• Perform Lab Tests: Independently carry out routine quality control analyses following set procedures.
• Data Integrity & Documentation : Confidently handle all steps of testing, including preparation, execution, and accurate documentation.
• Check Results: Review test results for accuracy and consistency before submission.
• Report Issues: Identify and report any quality deviations (e.g., OOS) according to protocols.
• Initial OOS Testing: Conduct first-level tests for out-of-spec results as per procedures.
• Escalate Issues: Identify recurring problems and escalate them to the appropriate person or team.
• Maintain Equipment: Take care of assigned lab equipment, including calibration and basic maintenance, following GMP and safety standards.
• Meet Deadlines: Complete tests and submit results within required timeframes.
• Follow Safety Rules: Work in line with all safety, health, and environmental (SHE) guidelines.
• Problem Solving: Analyze special samples to help resolve lab or support in production issues.
• Manage Supplies: Order and manage lab materials and reagents to avoid shortages.
• Flexibility: Perform other tasks as needed to support lab operations.
• Physical requirements: Requires stand for extended periods while performing inspections or quality checks, repetitive hand and arm movements to handle samples and to operate testing equipment, ability to maintain focus and attention to detail during routine and repetitive tasks.

Knowledge and educational level

• Education: Bachelor’s degree in science, or a related field preferred.
• Experience: Minimum of 2 years of experience in quality control.
• Fluency in local language a requirement, other languages encouraged.

Job Title: QC Microbiology Technician I

Location: Frederick, MD

Duration: 12+ Months

**Day Shift**

100% onsite (lab environment)

Shifts: 4/10 (4 days x 10 hours/day)

SUN-WEDS 7:00am-6:00pm

OR

WEDS-SAT 7:00am-6:00pm

Job Description

Working with the Quality Control team in supporting our efforts - cancer immunotherapy. This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, microbial growth promotion testing, utility testing and environmental monitoring.

Responsibilities (include but are not limited to):

• Perform environmental monitoring of cleanrooms

• Collect water samples to ensure all sample collected per schedule and tested on time

• Perform and review microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Growth Promotion, Bioburden and Plate Reading

• Perform and review visual inspection of final product

• Data entry and trend data as needed and prepare slides for management

• Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.

• Routine maintenance of lab equipment and lab spaces

• Review and approve all final product release test results

• Perform other duties as required

Basic Qualifications:

• AA Degree and 1+ years’ experience in Microbiology lab/Environmental Monitoring OR

• AA Degree and 2+ years’ experience in Microbiology lab/Environmental Monitoring OR

Preferred Qualifications:

• Experience in the application of microbiological techniques such as environmental air monitoring, water testing, surface monitoring

• Experience in aseptic techniques and clean room operations

• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.

• Ability to pass vision exam for visual inspection

• Knowledge of GMP, SOPs and quality control processes for commercial manufacturing

• Proficient in MS Word, Excel, Power Point and other applications

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

• Ability to be flexible with schedule, and work overtime as needed

• Ensure laboratory cleanliness, safety, and compliance with quality standards.
• Perform routine and non-routine testing of raw materials, in-process samples, environmental samples, and finished products.
• Interpret test results, investigate questionable or out-of-specification results, and recommend corrective actions.
• Develop, validate, and improve analytical methods and testing procedures. Maintain, calibrate, and troubleshoot laboratory equipment.
• Document testing activities, prepare technical reports, and revise standard operating procedures (SOPs).
• Coordinate testing with contract laboratories and vendors, review external data for accuracy and compliance, and support regulatory submissions.
• Participate in internal audits, method transfers, and quality investigations while providing technical support and training to other analysts.